Kratoms FDA Warning

TUESDAY, Nov. 14, 2017 (HealthDay News) — The U.S. Food and Drug Administration on Tuesday issued an advisory about harms tied to kratom — an imported herbal supplement with opioid-like effects that is increasing in popularity.

People are taking the unapproved supplement to treat conditions like pain, anxiety and depression — without medical supervision, FDA Commissioner Dr. Scott Gottlieb said in a statement. Others use kratom for its euphoric effects, or to wean addicts off opioids such as prescription painkillers or heroin, also without medical say-so.

“Importantly, evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and, in some cases, death,” Gottlieb said. “At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning.”

The United States is in the grip of an opioid epidemic. Since 2000, more than 500,000 Americans have died from a narcotic overdose, according to the U.S. Centers for Disease Control and Prevention. President Donald Trump recently declared the crisis a public health emergency.

Meanwhile, a similarly troubling trend has been seen with kratom. Between 2010 and 2015, kratom-related calls to U.S. poison control centers jumped 10-fold. And 36 deaths have been linked to kratom-containing products. Kratom use can also cause seizures, liver damage and withdrawal symptoms, the FDA said.

In the United States, there are no FDA-approved uses for kratom, which grows naturally in Southeast Asia.

In some cases reported to the FDA, kratom is laced with opioids like hydrocodone (Vicodin), Gottlieb noted.

The commissioner stressed the need to evaluate the drug’s potential benefits and harms. He said kratom products must go through the FDA’s drug review process before they can be legally marketed for therapeutic uses in the United States.

“This is especially relevant given the public’s perception that it can be a safe alternative to prescription opioids,” he added.

So far, no marketer has tried “to properly develop a drug that includes kratom,” Gottlieb said.

“While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound science and weighed appropriately against the potential for abuse,” Gottlieb added.

In 16 countries, kratom is a controlled substance. And in the United States, Alabama, Arkansas, Indiana, Tennessee and Wisconsin have banned kratom. Several other states are reviewing proposals to outlaw it, Gottlieb noted.

For now, the FDA said it is working to prevent shipments of kratom from entering the country.

“We’ve learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction, and we must take strong, decisive measures to intervene,” Gottlieb said.